Page 1 of 27 **UNITED STA**

**TES ENVIRONMENTA L PROTECTION A** **GENCY WA** **SHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND**  **POLLUTION PREVENTION**
**MEMORANDUM Date**  : May

15, 2014 **SUBJECT: Bifenazate**  **:** Occupational and Residential Exposure/ Risk Assessment for Proposed

Uses on Herb Subgroup 19A, Fruiting Vegetable Group 8
- 10, Pome Fruit Group 11
- 10, and Timothy

Grass Forage and Timothy Grass Hay
. **PC Code:** 0 00586 **DP Barcode:** D 3 8 8802 **Decision Nos.:** 446177 **Registration Nos. :**  59639
- 107 **Petition No.:** 1E7847 **Regulatory Action:** Section 3 **Risk Assessment Type:** Single Chemical Occupational/Residential Assessment **Case No.:** NA **T XR No.:**  NA **CAS No.:** 149877
- 41
- 8 **MRID No.:** NA **40 CFR:** § 180.5 72 **FROM:** Lata Venkateshwara, Environmental Scientist

Risk Assessment Branch 1 Health Effects Division (7509P) **THROUGH:** Kelly

M. Lowe, Environmental Scientist Charles Smith, Branch Chief Risk Assessment Branch 1 Health Effects Division (7509P) and Nancy Tsaur, Chemist, ExpoSAC Designated Reviewer Shalu Shelat, I

ndustrial Hygienist , ExpoSAC Designated Reviewer Exposure Science Advisory Committee (ExpoSAC) / HED **TO:** Barbara Madden , RM 0 5

Registration Division (7505P) Chemtura Corporation has proposed a Section 3 Registration ( PP# 1E7847 ) for application of b i fenazate to Herb Subgroup 19A (except chive and chervil), Fruiting Vegetable Group 8
- 10, Pome Fruit Group 11
- 10, and Timothy Grass Forage and Hay
. The Registration Division (RD) requested that the Health Effects Division (HED) conduct an exposure and risk assessment forPage 2 of 27

these proposed uses of bifenazate. This memorandum assesses occupational and residential exposure and risk from the use of bifenazate on the sites mentioned above. It is HED policy

to use the best available data to assess exposure. Sources of generic data, used as surrogate data in the absence of chemical
- specific data, include the Pesticide Handlers Exposure Database Version 1.1 (P HED 1.1), the Agricultural Handler Exposure Task Force (AHETF) database , the Outdoor Residential Exposure Task Force (ORETF) database; the Residential SOPs (Gardens and Trees), and the Agricultural Reentry Task Force (ARTF)
. Some of these data are proprie tary , and subject to the data protection provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This memorandum was reviewed b y the Exposure Science Advisory Committee (ExpoSAC ) on August 29, 201 3
.Page 3 of 27

**TABLE OF CONTENTS 1.0**  **Executive Summary**
................................ ................................ ................................ ........... 4 **2.0 Summary of Conclusions and Data Requirements** 
................................ ......................... 6 2.1 Summary

of Risk Estimates
................................ ................................ ............................. 6 2.2 Data Deficiencies and Requirements
................................ ................................ ............... 6 **3.0 Hazard Characterization** 
................................ ................................ ................................ ... 6 **4.0 Proposed Use Profile** 
................................ ................................ ................................ .......... 9 **5.0 Residential Exposure and Risk Estimates** 
................................ ................................ ..... 10 **5.1 Residential Handler Exposure/Risk Estimates** 
................................ .......................... 10 5.2 Residential Post
- application Exposure/Risk Estimates
................................ .................. 11 **5.3 Residential Risk Estimates for Use in Aggregate Assessments** 
................................ 12 5.4 Spray

Drift
................................ ................................ ................................ ...................... 13 5.5 Residential By stander Post
- Application Inhalation Exposure
................................ ....... 13 **6.0 Occupational Exposure and Risk Estimates** 
................................ ................................ .. 14 **6.1 Occupational**  **Handler Exposure/ Risk Estimates**
................................ ..................... 14 **Appendix A. Residential Handler and Post -**  **application Algorithms**
................................ .... 22 **Appendix B. Summary of Occupational and Residential Non -**  **cancer Algorithms**
............. 25 **Appendix C. Summaries of Dislodgeable Foliar Residue Studies and Proposed Use in Assessment** 
................................ ................................ ................................ ................................ ... 26Page 4 of 27

**1.0 E**  **xecutive S**  **ummary** This document presents an occupational and residential exposure/risk assessment for the proposed application of bifenazate to herb subgroup 19A (except chive and c h ervil), fruiting vegetable group 8
- 10, pome fruit group 11
- 10, and timothy grass forage and hay
. The proposed uses will not result in residential exposure; however, the currently registered gardens and ornamentals use has been reassessed in this document to reflect updates to HED’s 2012 Residential Standard Operating Procedures (SOPs). The residential exposures have been revised since they

will impact the aggregate assessment for bifenazate. Proposed Use Profile: Bifenazate is a selective miticide which controls the motile stage of mites either b y direct contact or through contact with foliar residues. The petition submitted by the Registrant includes addition of the fruiting vegetable group 8
- 10, herbs subgroup 19A (except chive and chervil), and pome fruit group 11
- 10 to the Acramite ® 50WS product label (EPA Reg. # 400
- 503). This product is formulated as a wettable
- powder (WP) in water
- soluble bags (WSB). Application is proposed at a maximum rate of 0.5 lb ai/A via ground and aerial application
. The petition also included addition of timothy forage and hay

to the Acramite ® 4SC product label (EPA Reg. # 400
- 514). This product is formulated as a suspension concentrate (flowable) . Application is proposed at a maximum rate of 0.75 lb ai/A via ground and aerial application, and chemigation. The proposed pre
- harvest intervals (PHIs) range from 0 to 7 day s. Hazard Concerns: HED identified a short
- and intermediate
- term dermal toxicological endpoint from a prenatal developmental toxicity rat study where the L OAEL is 8 0 mg/kg/ day
. An estimated 25% dermal absorption factor was used for calculating a dermal dose estimate. The short
- and i ntermediate
t erm inhalation endpoints were derived from the route specific 28
- day inhalation study

in rats where the NOAEL is 0.030 mg/L. The inhalation study NOAE L was converted to human equivalent concentrations (HECs ; 0.0009 and 0.00 39 mg/L for residential and occu pational exposures , respectivel y) and human equivalent doses (HEDs; 0.14 and 0.19 mg/kg/day for residential and occupational exposures , respectively)
. The level of concern for inhalation exposure is 3 0 which includes interspecies (3 x ) , and intraspecies (10 x ) uncertainty factors . The interspecies factor was reduced from 10x to 3x due to the HEC calculation accounting for pharmacokinetic (not pharmacodynamic) interspecies differences. The level of concern for dermal exposure is 100 which includes interspecie s (10x) , intraspecies (10x) , and FQPA (1x)
. The average adult body

weight of 80 kg was used for estimating dermal dose and 80 kg was used for estimating inhalation dose
. No evidence of carcinogenicity was seen in the rat and mouse studies and HED classified bifenazate as "not likely " to be a human carcinogen b y any relevant route of exposure. Residential Exposure/Risk: The proposed uses will not result in residential exposure; however, the currently registered garden and ornamental use has been reassessed in this document to reflect updates to HED’s 2012 Residential Standard Operating Procedures (SOPs). A total aggregated risk index (ARI) approach was used since the level s of concern (LOC s ) for dermal exposure (100) and inhalation exposure (30) are different. The dermal and inhalation exposure risk estimates for residentialPage 5 of 27

handlers are not of concern at baseline for all scenarios. All the ARIs are above 1 and do not excee d HED’s LOC for all scenarios. All adult and children (6 to 11 ye ars) dermal post
application risk estimates for exposure to treated trees and gardens are not of concern (margins of exposure or MOEs) ≥ 100). Occupational Handler Exposure : O ccupational handler short
- and intermediate
- term exposure is anticipated from the proposed uses. Chronic exposure is not expected for the proposed uses. Bifenazate is classified as “not likely to be carcinogenic to humans ; ” therefore, a cancer assessment was not conducted. The label for Acramite ®

- 50WS only requires protective eyewear, long
- sleeved shirt and long pants; shoes and socks. The label does not require gloves. The label for Acramite ®

- 4SC requires long
sleeved shirt and lon g pants, shoes plus socks. Itincludes a statement that “ When not using a closed sy stem , wear apron and chemically resistant gloves made of any waterproof material for mixing/loading activities. ” Inhalation risk estimates were not of concern for all scen arios. MOEs ranged from 100 to 12,000 (MOEs ≥ 30). Dermal risk estimates were not of concern for all scenarios. MOEs ranged from 110 to 33,000 (MOEs ≥ 100). All ARI s are greater than 1 except for the following scenarios that require single layer of glo ves:  Mixing/loading liquids for aerial and chemigation applications and  Mixing/loading/application of liquids via mechanically pressurized handgun (foliar). Occupational Post

- application Exposure: P ost - application dermal exposure will occur since bifenazate is applied post
- emergence as a foliar spray . Chemical
- specific DFR data were available and used for bifenazate. The short
- and intermediate
- term risk estimates are not of concern (i.e., (MOEs ≥100 ) ) on the day of treatment (i.e., Day 0) for the post
- application exposure activities. Based on the Agency's current practices, a quantitative occupational post
- application inhalation exposure assessment was not performed for bifenazate at this time. I f n ew policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post
- application inhalation exposure assessment for bifenazate. The 12
- hour REI listed on the label is adequate to protect agricultural workers from post
application exposures to bifenazate. Review of Human Research This risk assessment relies in part on data from studies in which adult human subjects were intentionally

exposed to a pesticide or other chemical. These data, which include Pestici de Handlers Exposure Database Version 1.1 (PHED 1.1); the Agricultural Handler Exposure Task Force (AHETF) database; the Outdoor Residential Exposure Task Force (ORETF) database ; and the Residential SOPs ( Gardens/Trees ), are (1) subject to ethics review pursuant to 40 CFR 26, (2) have received that review, and (3) are compliant with applicable ethics requirements. For certain studies, the ethics review may have included review b y the Human Studies ReviewPage 6 of 27

Board. Descriptions of data sources, as well as gui dance on their use, can be found at the Agency website 1

. **2.0 Summary of Conclusions and Data Requirements**  **2.1 Summary of Risk Estimates**  Residential Risk Estimate Summary: The dermal and inhalation exposure risk estimates for residential handlers are not of concern at baseline for all scenarios. All adult and children (6<11 years) dermal post
- application risk estimates for exposure to treated trees and treated gardens are not of concern (MOEs ≥ 100). Occupational Risk Estimate Summary : Occupational handler inhalation and dermal risk estimates were not of concern for all scenarios
. The interim Worker Protection Standard (WPS) restricted
- entry interval (REI) of 12 hours is adequate to protect agricultural workers. **2.2 Data Deficiencies and Requirements**  There are no data deficiencies or data requirements for the proposed new use of bifenazate. **3.0 Hazard Characterization**  The acute toxicity

data for bifenazate is summarized below in Table 3.1
. **Table 3.1 Acute Toxicity of Bifenazate.**  **Guideline No.**  **Study Type MRID #**  **Results Toxicity Category**  870.1100 Ac ute Oral 44464934 LD 50 > 5,000 mg/kg IV 870.1200 Ac ute Dermal 44464936 LD 50 > 5000 mg/kg IV 870.1300 Ac ute Inhalation 44464937 LC 50 > 4.4 mg/L IV 870.2400 Primary Eye Irritation 44464938 slight irritation IV 870.2500 Primary Skin Irritation 44464939 slight irritation IV 870.2600 Dermal Sensitization 45385101 dermal sensitizer Magnusson/Kligman 870.2600 Dermal Sensitization 44464940 not a dermal sensitizer Buehler Toxicological doses selected for use in this assessment are summarized in Table s 3 .2 and 3
. 3. The short
- and intermediate
- t erm dermal endpoints were derived from the 21
- day dermal rat study where the NOAEL is 80 mg/kg/day . The LOAEL is 40 0 mg/kg/day based upon decreased body weight in females, decreased food consumption in both sexes, increased urinary ketones, increased urin ary protein, increased urinary specific gravity , and decreased urinary volume in

1 http://www.epa.gov/pesticides/science/handler
- exposure - data.html and http://www.epa.gov/pesticides/science/post
- app - exposure - data.htmlPage 7 of 27

both sexes, and increased incidence s of extramedullary hematopoiesis in the spleen in both sexes. The level of concern is 100 based upon a 10x
- UF for inter
- species extrapolations, and a 10x
- UF fo r intra
- species variations. This study protects for the earl y resorptions in the developmental rat study where the maternal and fetal effects occur at the same dose. This study is appropriate for the route as well as the durations of exposure, in both residential and occupational s ettings.. The short
- and intermediate
- term inhalation endpoints were derived from the route
- specific 28
- day inhalation study

in rats where the NOAEL is 0.030 mg/L. The LOAEL is 0.075 mg/Lfor both sexes based on dried red material around the nose in females, lower body weights and weight gains, decreased food consumption, decreased heart and thy mus weights in females, increased incidences of mild brown pigmentation of the spleen, and minimal to mild degeneration of the olfactory epithelium within nasal levels III, IV, and V in both sexes. This study is appropriate for the route and duration of exposure, and is protective of adults in occupational and residential settings. The methods and dosimetry equations described in EPA’s RfC guidance (1994) are suited for calculating HECs based on the inhalation toxicity N OAEL for use in MOE calculations. The regional deposited
- dose ratio (RDDR), which accounts for the particulate diameter (mass median aerodynami c diameter [MMAD] and geometric standard deviatio n [  g ] of aerosols), can be used to estimate the different dose fractions deposited along the respiratory tract. The RDDR is also based on interspecies differences in ventilation and respiratory
- tract surface areas. Thus, the RDDR can be used to adjust an observed inhalation particulate exposure of an animal to the predicted inhalation exposure for a human. For the 4
- week inhalation study with bifenazate, an RDDR wa s estimated at 2.8 based on the reported mass medium aerodynamic diameter ( MMAD ) of 2.20 μ m and standard deviation (  g) of 2.78 and the respiratory
- tract surface area of the rat relative to the human. Since the rat inhalation study was carried out for 6 hr/day for 5 day s/week, the onl y exposure adjustment made was in the assumption of 8 hrs/day for human occupational exposures. The resulting HECs are 0.00 09 mg/L and 0.0039 mg/L for residential and occupational exposures , respectively
. The resulting HEDs are 0.14 and 0.19 mg/kg/day for residential and occupational exposures , respectively
. The level of concern for inhalation is 30 which includes interspecies (3x) and intraspecies (10x) uncertainty factors. The interspecies factor was reduced from 10x to 3x due to the HEC calculation accounting for pharmacokinetic (not pharmacodyn amic) inter species differences. The level of concern for dermal exposure is 100 which includes interspecies (10x), intraspecies (10x) , and FQPA (1x)
. The average adult body

weight of 80 was used for estimating dermal dose and 8 0 kg was used for estimating inhalati on dose. No evidence of carcinogenicity was seen in the rat and mouse studies and HED classified bifenazate as "not likely " to be a human carcinogen b y any relevant route of exposure.Page 8 of 27

**Table 3.2.**  **Summ ary of Toxicological Doses and Endpoints for Bifenaz**  **ate for Use in Dietary and Non**   ** Occupational Hum** **an -**  **Health Risk Assessments .**  **Exposure/ Scenario**  **P O**  **D Uncertainty/FQPA**  **SFs RfD, PAD,** 

**Level of Concern for**  **Risk Assessment**  **Study and Toxicological Effects**
Incidental Oral Short Term (1

- 30 days) and Intermediate Term NOAEL =

0.9 mg/kg/day UF A = 10x

UF H = 10x FQPA SF = 1x Residential

LOC for MOE = 100 **90 -**  **Day Subchronic -**  **Dogs**

LOAEL = 10.4 mg/kg/day based upon changes in hematological parameters in both sexes, increased bilirubin in the urine in males, increased absolute and relative liver weight in females and liver histopathologic al effects in both sexes. Dermal Short
and Intermediate
Term (1
- 30 days and 1
- 6 mo nths) LOAEL =

80 mg/kg/day UF A = 10x

UF H = 10x FQPA SF = 1x Residential

LOC for MOE = 100 **21 -**  **Day Derm al Toxicity**  **- Rat** 

LOAEL = 400 mg/kg/day based on decreased body weight in females, decreased food consumption in both sexes, increased urinary ketones, increased urinary protein, increased urinary specific gravity, and decreased urinary volume in both sexes, and increased incidence of extramedullary hematopoiesis in the spleen in both sexes.
Inhalation Short
- and Intermediate
Term (1
- 30 days, and 1
- 6 mo nths) Rat

NOAEL = 0.03 mg/L UF A = 3 x

UF H = 10x FQPA SF = 1x Residential

LOC for MOE = 30 **28 -**  **Day Inhalation Toxicity**  **- Rat** 

LOAEL = 0.075 mg/L [M/F] on dried red material around the nose in females, lower body weights and body
- we ight gains, decreased food consumption, decreased heart and thymus weights in females, increased incidences of mild brow n pigmentation of the spleen, and minimal to mild degeneration of the olfactory epithelium within nasal levels III, IV, and V. HEC= 0.0009 mg/L HED = 0.14 mg/kg bw /day Cancer (oral, dermal, inhalation) Bifenazate is classified as "not likely to be a human carcinogen”. Point of departure (POD) = a data point or an estimated point that is derived from observed dose
- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no - observed adverse
- effect level. LOAEL = lowest
- observed adverse
- effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population
- adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable.Page 9 of 27

**Table 3.3**  **Summary of Toxicological Doses and Endpoints for Bifenazate for Use in Occupational Hum an**  **Health Risk Assessments Exposure/**  **Scenario POD**  **Uncertainty Factors**  **Level of Concern**

**for Risk Assessment**  **Study and Toxicological Effects** 

Dermal Short
and Intermediate
Term (1
- 30 days and 1
- 6 mo nths) LOAEL =

80 mg/kg/day UF A = 10x

UF H = 10x Occupational

LOC for MOE = 100 **21 -**  **Day Derm al Toxicity**  **- Rat** 

LOAEL = 400 mg/kg/day based on decreased body weight in females, decreased food consumption in both sexes, increased urinary ketones, increased urinary protein, increased urinary specific gravity, and decreased urinary volume in both sexes, and incre ased incidence of extramedullary hematopoiesis in the spleen in both sexes. Inhalation Short
- and Intermediate
Term (1
- 30 days, and 1
- 6 mo nths) Rat NOAEL

= 0.03 mg/L UF A = 3 x

UF H = 10x Occupational

LOC for MOE = 30 **28 -**  **Day Inhalation Toxicity -**  **Rat**

LOAEL = 0.075 mg/L [M/F] based on dried red material around the nose, lower body weights and body
- we ight gains, decreased food consumption, mild brown pigmentation of the spleen, and minimal to mild degeneration of the olfactory epithelium within nasal levels III, IV, and V in both sexes. HEC = 0.0039 mg/L HED = 0.19 mg/kg bw /day Cancer (oral, dermal, inhalation) Bifenazate is classified as "not likely” to be a human carcinogen. POD = a data point or an estimated point that is derived from observed dose
- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no
- observed adverse
- effect level. LOAEL = lowest - observed adverse
- effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). MOE = margin of exposure. LOC = level of concern. **4.0 Proposed Use Profile**  Table 4 .1 provides a summary of the proposed use patterns . Acramite ® 50WS is formulated as a wettable
- powder (WP) in water
- soluble bags (WSB). It is proposed for use on fruiting vegetable group 8
- 10, herbs subgroup 19A (except chive and chervil), and pome fruit group 11
- 10 at a maximum application rate of 0.5 lb ai/A via ground and aerial application. Acramite ® 4SC is formulated as a suspension concentrate (flowable) and is proposed for use on timothy forage and hay at a maximum application rate of 0.75 lb ai/A via ground and aerial application, and chemigation. The propo sed pre
- harvest intervals (PHIs) range from 0 to 7 day s. The Acramite ® 4SC label requires applicators and other handlers to wear a long
- sleeved shirt and long pants and shoes plus socks, plus an apron and chemical
- resistant gloves of any waterproof material for mixing/loading activities (when not using a closed s ys tem). The Acramite® 50WS label requires applicators and other handlers to wear protective eyewear, long
- sleeved shirt and long pants, and shoes plus socks. The label does not require gloves.Page 10 of 27

**Ta ble 4.1. Summary of Proposed Directions for Use of Bifenazate**  **. Comm**  **odity Trade** 

**Nam e**  **(EPA Reg. No.)**  **Application**

**Timing, Type, Equipment**  **Applicatio**

**n Rate (lb ai/A)**  **Maximum**

**Seasonal Application**  **Rate (lb ai/A)**  **PHI**

**(days) Maximum** 

**Number Applications**  **Min. GPA**
Herbs subgroup 19A (except chives, chervil) Acramite

® 50WS (400
- 503) Groundboom

Aerial Airblast Handheld 0.5 0.5 3

1 50 (ground) Fruiting vegetable group 8
- 10 3 50 (ground); 10 (air) Pome fruit group 11
- 10 7 50 (ground) Timothy forage and hay 1 Acramite

® 4SC (400
- 514) Groundboom

Chemigation Aerial Handheld 0.75 0.75 0 (forage) 20 (ground); 10 (air) 7 (hay) PHI = pre
- harvest interval GPA = gallons of water per acre 1 Application can only be made in Eureka and Humboldt Counties in Nevada
**5 .0**  **R esidential Exposure and Risk Estimates**  The proposed uses do not involve applications by homeowners or commercial applicators in residential settings. Therefore, no new residential exposure is expected. H owever, there are existing residential uses that have been reassessed in this document to reflect updates to HED’s 2012 Residential SOPs (http://www.epa.gov/pesticides/science/residential
- exposure - sop.html ) along with policy

changes for body

weight assumptions. The revision of residential exposure estimate s will impact the human health aggregate risk assessment for bifenazate. **5 .1**  **R esidential Handler Exposure/Risk Estimates**  The residential handler exposure assessment estimates dermal and inhalation exposures for individuals using bifenazate on residential ornamentals. The quantitative exposure/risk assessment developed for residential handlers is based on the following scenarios: (1) mixing/loading/appl yi ng liquids with manually
- pressurized hand wand, (2) mixing/loading/appl yi ng liquids with hose
- end sprayer, (3) mixing/loading/appl yi ng liquids with backpack, and (4) mixing/loading/appl yi ng liquids with sprinkler can. Unit exposure values and estimates for area treated were taken from HED’s 2012 Residential SOPs: Gardens and Trees. Combining Exposures/Risk Estimates:Page 11 of 27

A total aggregated risk index (ARI) was used since the LOCs for dermal exposure (100) and inhalation exposure ( 30 ) are different. The target ARIis 1; therefore, ARIs of less than 1 are risk estimates of concern. The aggregate risk index (ARI) was calculated as follows. Aggregate Risk Index (ARI) = 1÷ [ ( Dermal LOC ÷ Dermal MOE ) + ( Inhalation LOC ÷ Inhalation MOE ) ] Short
- term risk estimates for residential handlers are presented in Table 5.1. Intermediate
- term exposures are not likel y because of the intermittent nature of applications by homeowners. Short
- term dermal and inhalation risk estimates to residential han dlers do not exceed HED’s level of concern for all scenarios. All the ARIs are above 1 and do not exceed HED’s level of concern for all scenarios. **Table 5.1. Residential Handler Exposure and Risk Estimates for Bifenazate Applications to Ornamentals .**  **Exposure Scenario**  **Application**

**Rate 1**  **Area**

**Treated Daily**  **2 Baseline Unit** 

**Exposures ( mg** **/lb ai) Baseline Dose**  **4 (m**  **g/k g/day)**  **Baseline MOE 5**  **Total Dermal**  **3 Inhalation**  **3 Dermal**  **Inhalation Dermal**  **(LOC = 100)**  **Inhalatio**

**n (LOC =**  **30)** ARI 6 **Mi xer/Loader/Applicator for**  **Soluble Concentrates( Liquids)** Manually
pressurized handwand 0.00125 lb

ai/gal 5 gal 63 0.018 0.00 49 0.0000014 1 6 , 000 100,000 150 Hose
- end sprayer 0.00125 lb

ai/gal 11 gal 58 0.0014 0.01 0.00000024 8 , 000 580,000 80 Backpack 0.00125 lb

ai/gal 5 gal 130 0.14 0.01 0.000011 7 , 9 00 13,000 66 Sprinkler can 0.00125 lb

ai/gal 5 gal 58 0.0014 0.0045 0.00000011 18 , 000 1,300,000 180 1. Application rates based on communication between the Registrant and EPA regarding the maximum rates allowed on the labels for the residential use sites. From label 400
- 508: 2.0 lb ai/gal/128 fl oz gal * 8 fl oz/100 gal = 0. 00 125 lb ai/gal 2. Based on HED’s SOPs: Gardens and Trees (HED’s 2012 Residential SOPs) 3. Baseline Dermal: Long
- sleeve shirt, long pants, shoes and socks and no gloves; Baseline Inhalation: no respirator. 4. Dose (mg/kg/day) = daily unit exposure (mg/ lb ai) x application rate (lb ai/gal) x gal treated x % Absorption ( 100 % dermal and 100% inhalation assumed) / Body weight ( 80 kg). 5. MOE = NOAEL (Dermal = 8 0 mg/kg/day; Inhalation = 0.1 4 mg/kg/day) / daily dose (mg/kg/day). 6. ARI = Aggregate Risk Index = 1÷ [(Dermal LOC ÷ Dermal MOE) + (Inhalation LOC÷ Inhalation MOE)]. **5.2 Residential Post** **- application Exposure/Risk Estimates**  Non
- cancer Exposure/Risk Estimates Short
- term dermal exposure and risk estimates have been assessed for bifenazate. The scenarios, routes of exposure and lifestages assessed include:

 Gardens and Trees: adults (dermal) and children 6< 11 years old (dermal). The lifestages (i.e ., adults and children 6 < 11 ye ars old) selected for each post
- application scenario are based on an anal ys is provided as an Appendix in the 2012 Residential SOPs. These lifestages are not the only lifestages that could be potentially exposed for these po st - application scenarios; however, the assessment of these lifestages is health protective for the exposures and risks for any other potentially exposed lifestages. Residential Post
- application Exposure Data and AssumptionsPage 12 of 27

A series of assumptions and exposure factors served as the basis for completing the residential post - application risk assessment. Each assumption and factor is detailed in the 2012 Residential SOPs (http://www.epa.gov/pesticides/science/residential
- exposure - sop.html ). Residential Post
- application Non
- Cancer Exposure and Risk Equations The algorithms used to estimate residential post
- application exposure and dose can be found in the 2012 Residential S OPs (http://www.epa.gov/pesticides/science/residential
- exposure sop.html ). For this assessment a DFR value was used. Table 5.2 lists the updated assessments of currently registered residential post
- application exposures and risk estimates . All adult and children dermal post
- application risk estimates for exposure to treated trees and to treated gardens are not of concern (MOEs ≥ 10 0
. **Table 5.2. Short**  **- and Intermediate**  **- T**  **erm Residential Post -**  **application Exposure and Risk Estimates for Bifenazate.**  **Liquid Formulations Lifestage**  **Post -**  **application Exposure Scenario Dose**  **a MOEs**  **b (LOC = 100)**  Adult Garden
- sprays 0.037 2,200 Child 6 < 11 years old 0.025 3,100 Adult Tree

– sprays 0.0034 23,000 Child 6 < 11 years old 0.0023 34,000

a . Dermal Dose (mg/kg/day) = DFRt (μg/cm2 ) x 0.001 (mg/μg) x short
- term TC (cm2/hr) x ET (hr/day) x Dermal Absorption ( 100 %) BW (kg) b. Dermal MOE = NOAEL ( 8 0 mg/kg/day) / Dermal Dose (mg/kg/day) Inhalation Based on the Agency's current practices, a quantitative post
- application inhalation exposure assessment was not performed for bifenazate at this time . However, volatilization of pesticides may be a potential source of post
- application inhalation exposure to individuals nearb y to pesticide applications. The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory

Panel (SAP) in December 2009. The Agency received the SAP’s final report on March 2, 2010 (http://www.epa.gov/scipoly /SAP/meetings/2009/120109meeting.html ). The Agency is in the process of evaluating the SAP report and may , as appropriate, developing policies and procedures, to identifying the need for and, subsequentl y, the way to incorporate post - application inhalation exposure into the Agency's risk assessments. If new policies or procedures are put into place, the Agen cy may revisit the need for a quantitative post
- application inhalation exposure assessment for bifenazate. **5.3 Residential Risk Estimates for Use in Aggregate Assessments**  Table 5.3 reflects the residential risk estimates that are recommended for use in the aggregate assessment for bifenazate.  The recommended residential exposure for use in the adult aggregate assessment reflects dermal post
- application exposure to treated gardens.  The recommended residential exposure for use in the children 6 to 11 ye ars old aggregate assessment reflects dermal post
- application exposure to treated gardens.Page 13 of 27

**Table 5.3**  **. Short**  **- Term** **Residential Exposures for the Bifenazate Com bined Residential Risk**  **Calculations .**  **Population Handler Exposure** 

**(m g/kg/day)**  **1 Post**  **- application Exposure**  **(m g/kg/day)**  **2 Recommended Post**  ****

**application Exposure for Aggregate**  **(m g/kg/day)**  **3 Derm**  **al Inhalation**  **Derm al**  **Inhalation Oral**  Adult 0.0045 0.000011 0.0 37 N/A N/A 0.037 Children 6 < 11 yrs old N/A N/A 0.0 25 N/A N/A 0.025 1
. Handler exposure represents high
- end handler exposure, where the appropriate duration is appropriate to assess. 2
. Postapplication exposure represents high
- end dermal, inhalation and/or incidental oral exposure for the relevant exposure duration. 3
. The highest estimated total residential exposure (for adults and child populations) should be used as the basis of the aggregate assessments. **5.4 Spray Drift**  Spray drift is a potential source of exposure to those nearb y pesticide applications . This is particularl y the case with aerial application, but, to a lesser extent, spray drift can also be a potential source of exposure from the ground application method s (e.g., groundboom and airblast) employed for bifenazate **.** The Agency has been working with the Spray Drift Task Force ( a task force composed of various registrants which was developed as a result of a Data Call
- Inissued by

EPA) , EPA Regional Offices and State L ead Agencies for pesticide regulation and other parties to develop the best spray drift management practices (see the Agency ’s Spray Drift website for more information)
. 2 The Agency is also taking means to qualitatively and qualitatively

address spray

drift as a potential source of exposure in risk assessments for pesticides through existing programs such as Ag Drift and chemical specific properties of pesticides. The potential for spray drift will be quantitatively evaluated for each pesticide during the Registration Review process which ensures that all uses for that pesti cide will be considered concurrently
. **5.5 Residential Bystander**  **Post -** **Application Inhalation Exposure** Based on the Agency's current practices, a quantitative post
- application inhalation exposure assessment was not performed for bifenazate at this time p rimarily because of the low acute inhalation toxicity

(Toxicity Category IV), low vapor pressure (<1 x 10 - 7 mm Hg @ 25°), and the low proposed use rate (0.75 lb ai/A ). However, volatilization of pesticides may be a source of post - application inhalation e xposure to individuals nearb y pesticide applications. The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009 , and received the SAP’s final report on March 2, 2010 (http://www.epa.gov/scipoly /SAP/meetings/2009/120109meeting.html ). The Agency is in the process of evaluating the SAP report and may , as appropriate, develop policies and procedures to identify the ne ed for and, subsequently , the way to incorporate post
- application inhalation exposure into the Agency's risk assessments. If new policies or procedures are developed, the Agency may revisit the need for a quantitative post
- application inhalation exposure assessment for bifenazate.

2 Available: http://www.epa.gov/opp0000 1/factsheets/spraydrift.htmPage 14 of 27

**6.0 O**  **ccupational Exposure and Risk Estimates** The proposed uses are on agricultural crops; therefore, there is potential for occupational handler and post
- application exposure. **6.1 Occupational Handler Exposure/ Risk**  **Estimates** HED uses the term handlers to describe those individuals who are involved in the pesticide application process. HED believes that there are distinct job functions or tasks related to applications and exposures can vary depending on the specific s of each task. Job requirements (amount of chemical used in each application), the kinds of equipment used, the target being treated, and the level of protection used b y a handler can cause exposure levels to differ in a manner specific to each applicati on event. Based on the anticipated use patterns, current labeling, and types of equipment that can potentially

be used, occupational handler exposure is expected from the proposed uses. The quantitative exposure/risk assessment developed for occupational handlers is based on the following scenarios: Mixer/L oader: 1. mixing/loading water soluble bags (engineering controls for the wettable powder scenario) for aerial application; 2. mixing/loading water soluble bags (engineering controls for the wettable powder scenario) for groundboom application; 3. mixing/loading water soluble bags (engineering controls for the wettable powder scenario) for airblast application; 4. open mixing/loading liquids for aerial application; 5. open mixing/loading liquids for groundboom application; 6. open mixing/loading liquids for chemigaton; Applicator: 7. application of spray s via aerial application; 8. application of spray s via groundboom equipment; 9. application of spray s via airblast application; 10. application of spray s via chemigation; Mixer/L oader/Applicator: 11. application of liquids via mechanically pressurized handgun (foliar); 12. application of wettable powder in water soluble bags via mechanicall y pressurized handgun (foliar); and Flagger: 13. flagging to support aerial spray applications. Occupational Handler Exposure Data and Assumptions A series of assumptions and exposure factors served as the basis for completing the occupational handler risk assessments. Each assumption and factor is det ailed below on an individual basis.Page 15 of 27

Application Rate: Maximum applications rates as provided in Table 4.1 were used in the assessment. Unit Exposures: It is the policy

of HED to use the best available data to assess handler exposure. Sources of generic handler data, used as surrogate data in the absence of chemical
- specific data, include the Pesticide Handlers Exposure Database (PHED 1.1), the Agricultural Handlers Exposure Task Force (AHETF) database, the Outdoor Residential Exposure Task Force (ORETF) database, or other registrant
- submitted occupational exposure studies. Some of these data are proprietary (e.g., AHETF data), and subject to the data protection provisions of FIFRA. The standard values recommended for use in predicting handler exposure that are used in this assessment, known as “unit exposures”, are outlined in the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table 3 ”, which, along with additional information on HED policy on use of surrogate data, including de scriptions of the various sources, can be found at the Agency website 4

. Area/Amount Treated: Based on HED ExpoSAC Standard Operating Policy (SOP) No. 9.1, the area treated in a day was assumed to be:  80 acres for groundboom applications,  350 acres for aerial and chemigation applications,  40 acres for airblast applications, and  350 acres for flagging to support aerial treatment. Body Weight: The average adult body

weight of 80 kg was used for estimating dermal dose because the selected toxicological P ODs are based on developmental effects. The average adult body weight of 80 kg was used for estimating inhalation dose because the selected toxicological PODs are not based on developmental effects. Exposure Duration : HED classifies exposures from 1 t o 30 day s as short
- term and exposures and 30 day s to six months as intermediate
- term. Exposure duration is determined by many things, including the exposed population, the use site, the pest pressure triggering the use of the pesticide, and the cultural p ractices surrounding that use site. For most commercial pest control, it is reasonable to believe that occupational handlers will not apply the same chemical every day for more than a one - month time frame; however, commercial applicators may appl y a produ ct over a period of weeks. Long
- term exposure is not expected. Note, according to the label there is a maximum of 1 spray per season at a maximum rate of 0.5 lb ai/ A for herbs subgroup 19A, fruiting vegetable groups 8
- 10 and pome fruit group 11
- 10 and 0 .75 lb ai/A for timothy

forage and hay . Long
- term exposures are not expected; therefore, a long
- term assessment was not conducted.

3 Available: http://www.epa.gov/opp00001/science/handler
- exposure - table.pdf 4 Available: http://www.epa.gov/pesticides/science/handler
- exposure - data.htmlPage 16 of 27

Mitigation Approaches: For pesticide handlers, it is HED’s standard practice to present estimates of dermal exposure for “baseline” that is, for workers wearing a single layer of work clothing consisting of a long sleeved shirt, long pants, shoes plus socks and no protective glo ves, as well as for “baseline” and the use of protective gloves or other Personal Protective Equipment (PPE) as might be necessary
. The Acramite ® 4SC label requires applicators and other handlers to wear a long
- sleeved shirt and long pants and shoes plus socks, plus an apron and chemical
- resistant gloves for mixing/loading activities (when not using a closed s ys tem). The Acramite® 50WS label requires applicators and other handlers to wear protective eyewear, long
- sleeved shirt and long pants, and shoes plu s socks. The label does not require gloves. Application Rate: Refer to the proposed use patt ern table in Section 4.0. Occupational Handler Non

- Cancer Exposure and Risk Estimate Equations The algorithms used to estimate non
- cancer exposure and dose for occupational handlers can be found in Appendix B
. A total aggregated risk index (ARI) was used since the LOC values for dermal exposure (100) and inhalation exposure ( 30 ) are different. The target ARI is 1; therefore, ARI s of less than 1 are risk estimates of concern. The aggregate risk index (ARI) was calculated as follows. Aggregate Risk Index (ARI) = 1÷ [(Dermal LOC ÷ Dermal MOE) + (Inhalation LOC ÷ Inhalation MOE) ] Summary of Occupational Handler Non
- Cancer Exposure and Risk Estimates Table 6.1.1 provides a summary of the estimated exposures and risks to occupational pesticide handlers. An MOE ≥ 100 is adequate to protect occupational pesticide handlers from dermal exposures and an MOE ≥ 30 from i nhalation exposures. Inhalation and dermal risk estimates were not of concern for all scenarios. All ARIs are greater than 1 and are not risks of concern , except for the following scenarios that require single layer of gloves:  Mixing/loading liquids for aerial and chemigation applications and  Mixing/loading/application of liquids via mechanically pressurized handgun (foliar).
**Table 6.1.1.**  **Short -** **/Interm ediate**  **- Term** **Occupational Exposure and Risk Estim ates for Bifenazate.**  Exposure Scenario Dermal Unit

Exposure (ug/lb ai) 1 Inhalation Unit

Exposure (ug/lb ai) 1 Application

Rate 2 Amount

Treated Daily3 Dose (mg/kg/day) 4,5 MOE 6,7 Total

Dermal Inhalation Dermal (LOC = 10 0 ) Inhalation (LOC = 30) ARI 9 **Mi xer/Loader Wettable**  **Powder in Water Soluble Bags** Aerial Application Eng Control 8 :

9.8 Eng Control 8 :

0.24 0.5 lb ai/A 350 A EC : 0.0 215 EC : 0.00053 EC : 3, 7 00 EC : 360 EC : 9.1 Airblast Applications 0.5 lb ai/A 40 A EC : 0.00 245 EC : 0.00006 EC : 33 ,000 EC : 3,200 EC : 81 Groundboom applications 0.5 lb ai/A 80 A EC : 0.00 49 EC : 0.00012 EC : 16 ,000 EC : 1,600 EC : 40 **Mi xer/Loader Liquids** Page 17 of 27 **Table 6.1.1.**  **Short -** **/Interm ediate**  **- Term** **Occupational Exposure and Risk Estim ates for Bifenazate.**  Exposure Scenario Dermal Unit

Exposure (ug/lb ai) 1 Inhalation Unit

Exposure (ug/lb ai) 1 Application

Rate 2 Amount

Treated Daily3 Dose (mg/kg/day) 4,5 MOE 6,7 Total

Dermal Inhalation Dermal (LOC = 10 0 ) Inhalation (LOC = 30) ARI 9 Aerial Application Base:220 Base: 0.219 0.75 lb ai/A 350 A Base: 0. 723 SL/G: 0.123 Base: 0.00072 Base: 110 SL/G: 650 Base: 260 Base: 0.98 SL/G: 3. 7 Chemigation Applications 0.75 lb ai/A 350 A Base: 0. 723 SL/G: 0.123 Base: 0.00072 Base: 110 SL/G: 650 Bas e: 260 Base : 0.98 SL/G: 3. 7 Groundboom applications 0.75 lb ai/A 80 A Base: 0. 165 Base: 0.000 16 Base: 48 0 Base: 1,200 Base: 4. 3 **Applicator** Applicator, Aerial EC: 2.08 EC : 0.0049 0.75 lb ai/A 350 A EC: 0.00 683 EC : 0 .0000161 EC: 12 ,000 EC : 12,000 EC : 92 Applicator, Open Cab Groundboom Base: 78.6 Base: 0.34 0.75 lb ai/A 80 A Base : 0 .0 0365 Base : 0. 443 Base : 180 Base: 750 Base: 1. 3 Applicator, Open Cab, Airblast Base: 1770 Base: 4.71 0.5 lb ai/A 40 A Base : 0
. 00383 Base: 0.059 Base: 1,400 Base: 160 Base: 9 **Mi xer/Loader/Applicator**  Mixing/Loading Applying Liquids with Mechanically Pressurized Handgun (foliar) Base: 1,300

SLw/G: 390 Base: 3.9 0.0375 lb ai/gallon 1,000

Gallons Base : 0. 61 Base : 0.00183 Base : 130

SLw/G:440 Base : 100 Base : 0 .94 SLw/G : 1.9 Mixing/Loading Applying Water Soluble Packets with Mechanically Pressurized Handgun (foliar) Base : 1,300 Base : 3.9 0.01 lb ai/gallon 1,000

Gallons Base: 0.163 Base : 0.000488 Base : 490 Base : 390 Base : 3. 6 **Flagger** Flagger Base :

11 Base : 0.35 0.75 lb ai/A 350 A Base : 0.0 361 Base : 0.0011 Base : 2,200 Base : 170 Base: 4.5 1 Based on “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” (March 2013); includes data from PHED /AHETF (level of mitigation: Baseline, PPE, Eng. Controls). : Base = single layer and no gloves; no respirator; SL w/G = single layer w/glove; EC = Engineering control; PF5 = dust/mist respirator. 2 Based on proposed labels for bifenazate (see Table 4.1 ). 3 Exposure Science Advisory Council Policy #9.1. 4 Dermal Dose = Dermal Unit Exposure (ug/lb ai) x CF (0.001 mg/ug) x Application Rate (lb ai/acre) x Area Treated (A/day) x % Absorption (100% dermal) / Body weight (80 kg). 5 Dermal MOE = Dermal NOAEL (80 mg/kg/day)/Dermal Dose (mg/kg/day). 6 Inhalation Dose = Inhalation Unit Exposure (ug/lb ai) x CF (0.001 mg/ug) x Application Rate (lb ai/ acre) x Area Treated (A/day) /BW (80 kg). 7 Inhalation MOE = Inhalation NOAEL (0.19 mg/kg/day)/ Inhalation Dose (mg/kg/day). 8 Engineering controls for the wettable
- powder scenario. 9 ARI = Aggregate Risk Index = 1÷ [(Dermal LOC ÷ Dermal MOE) + (Inhalation LOC ÷ Inhalation MOE)]. **6.2 Post**  **- application Exposure/ Risk**  Dermal HED expects that post
- application dermal exposure will occur since bifenazate is applied post
emergence as a foliar spray to upper and lower leaf surfaces. Post
- application e xposure is expected to be short
- and intermediate
- term based on information provided on proposed labels (e.g., according to the label there is a maximum of 1 spray per season at a maximum rate of 0.75Page 18 of 27

lb ai/A). Only

short
- term exposure was assessed, howev er the assessment is protective of intermediate
- term exposures since the dermal endpoints are the same. Data and Assumptions for Post
- application Exposure Scenarios It is the policy

of HED to use the best available data to assess post
- application exp osure. Sources of generic post
- application data, used as surrogate data in the absence of chemical
specific data, are derived from Agricultural Reentry Task Force (ARTF) exposure monitoring studies, and, as proprietary data, are subject to the data protec tion provisions of FIFRA. The standard values recommended for use in predicting post
- application exposure that are used in this assessment, known as “transfer coefficients”, are presented in the “Science Advisory Council for Exposure (ExpoSAC) Policy 3” (http://www.epa.gov/pesticides/science/exposac_policy3.pdf), which, along with additional information about the ARTF data, can be found at http://www.epa.gov/pesticides/scien ce/post
app - exposure - data.html . Table 9 provides a summary of the transfer coefficients and activities associated with Herb Subgroup 19A (except chive and chervil), Fruiting Vegetable Group 8
- 10, Pome Fruit Group 11
- 10, and Timothy Grass Forage and Timothy Grass Hay
. Table 6.2.1 summarizes the possible scenarios. In addition, the following assumptions were used in the calculations:

• Exposure Duration: 8 hours per day
• Body Weight: 80 kg for dermal and 80 kg for inhalation
• **Table 6.2.1. Anticipated Post** **- application Activities and Derm**  **al Transfer Coefficients .**  Proposed Crops Policy Crop

Group Category Application Rate

(lb ai/acre) Transfer Coefficients (cm 2/hr) Activities

Fruiting vegetable group 8
- 10 Vegetable,

fruiting 0.5 1,900 Irrigation (hand
- set) 1,100 Harvesting (hand),

tying/training 550 Harvesting (hand),

tying/training 230 Transplanting 210 Scouting 90 Hand pruning, scouting,

hand weeding, thinning
Herbs subgroup 19A (except chives, chervil) Vegetable,

leafy* 0.5 1,900 Irrigation (hand
- set) 1,400 Hand harvesting 230 Transplanting 210 Scouting 70 Hand weeding, thinningPage 19 of 2 7

**Table 6.2.1. Anticipated Post** **- application Activities and Derm**  **al Transfer Coefficients .**  Proposed Crops Policy Crop

Group Category Application Rate

(lb ai/acre) Transfer Coefficients (cm 2/hr) Activities

Pome fruit group 11
- 10 Tree, “fruit,”

deciduous 0.5 3,600 Thinning 1,400 Hand harvesting 580 Scouting, hand pruning, training 230 Transplanting 100 Hand weeding, propping,

orchard maintenance, bird control
Timothy forage and hay Field/row

crop, low /medium 0.75 1,900 Irrigation (hand
- set) 1,100 Scouting 210 Scouting 70 Hand weeding, thinning *Activities and transfer coefficients associated with parsley considered to be representative for new use site. Chemical
- specific DFR data were available for bifenazate; however, the data were not for the currentl y proposed crops. Since DFR data are not available for the specific crops currentl y proposed for bifenazate, the available data were used as surrogates. Based on a review of the available data, it was decided that the DFR data for Spathiphyllum (Peace Lily) in greenhouses would be used as a surrogate for the proposed field crops (fruiting vegetable group 8
- 10, herb subgroup 19 A, pome fruit group 11
- 10, and timothy forage and hay). Even though the data are not for the specific crops, it is the only chemical
- specific data submitted to HED. There are several limitations that were considered such as (1) the study represents DFR data collected in a greenhouse which may potentially

be a more conservative estimate of residue dissipation compared to field crops, (2) the formulation in the study is a wettable powder packaged in a water soluble bag whereas one of the proposed labels (EPA Reg.#400
- 514) is for a product that is a suspension concentrate (liquid), (3) the application rate was lower in the s tudy

(0.29 lb ai/A) compared to the proposed labels (0.5 lb ai/A and 0.75 lb ai/A), and (4) the application was made with a calibrated hand
- held boom sprayer. Tables 6.2.2 provide a summary of the data for use in the post
- application exposure and risk c alculations. Appendix C provides summaries of the studies and references. **Table 6.2.2. Summary of DFR Values and Regression Analysis Results for Treated Spathiphyllum**  **(Peace Lily) in Greenhouses with Bifenazate (MRID# 448597**  **- 01).** 

**Input/Parameter Site: Florida**  **Bifenazate** Application Rate (lb ai/A) a Study Target Rate = 0.29 lb ai/A 0.29 lb ai/APage 20 of 27

**Table 6.2.2. Summary of DFR Values and Regression Analysis Results for Treated Spathiphyllum**  **(Peace Lily) in Greenhouses with Bifenazate (MRID# 448597**  **- 01).** 

**Input/Parameter Site: Florida**  Spray Volume (GPA) 5 gallons/1000 ft2 Measured Average Day 0 Residue (μg/cm2 ) 0.151 Predicted Day 0 Residue (μg/cm2 ) b 0.161 Slope
- 0.07 Half
- life (days) 9.9 R2 0.8433 a. The application was conducted using hand
-held boom sprayer. b. Regressions are based on data collected after second application. The following equations were used to calculate risks for workers performing postapplication activities: Daily Dermal Dose t = (DFR t x CF1 x TC x DA x ET) / BW Where: Daily Dermal Dose = Absorbed dose received from exposure to a pesticide in a given scenario on day “t” (mg/kg/day), DFR t = dislodgeable foliage residue on day "t" (μg/cm2 ), CF1 = conversion factor ( 1E
- 3 mg/μg), TC = transfer coefficient (cm 2/hr), DA = dermal absorption factor (unitless), ET = exposure time (hr/day), and BW = body weight (kg).
MOE = Point of Departure (mg/kg/day) / Daily Dermal Dose (mg/kg/day) HED has determined that short
- and intermediate
- term risk estimates are not of concern (i.e., MOEs < 100) on the day

of treatment (i.e., Day

0) for all the post
- application exposure activities. Estimates were calculated for the highest transfer coefficients and are protective of all other activities. Table 6.2.3 presents the risk estimates for all crops for the highest transfer coefficient associated with that crop; this represents the activities with the highest estimated risk.

**Table 6.2.3**  **. Dermal Post**  **- application Exposure and Risk for Bifenazate Using Chemical**  **- Specific DFR Data.**  **Crop Application** 

**Rate (lb ai/A)**  **Highest Transfer**

**Coefficient for Crop (cm**  **2 /hr)**  **and Associated Activity**  **DFR 1** 

**(ug/cm 2**  **) Days After** 

**Treat me**  **nt Daily Dose**  **2**

**(m g/k** **g/ day)**  **MOE 3**  Fruiting vegetable Group 8
- 10 0.5 1,900 (irrigation; hand
set) 0. 278 0 (12 hours) 0.0 528 1 ,500 Herbs S ubgroup 19A 0.5 1,900 (irrigation; hand
- set) 0. 278 0 (12 hours) 0.01 528 1 ,500 Pome fruit Group 11
- 10 0.5 3,600 (thinning fruit) 0. 278 0 (12 hours) 0. 10 800 Timothy forage and hay 0.75 1,900 (irrigation; hand
set) 0. 416 0 (12 hours) 0.0 79 1 ,000Page 21 of 27

1. Chemical
- specific DFR = predicted chrysanthemum DFR data for Spathiphyllum (Peace Lily) in greenhouses for a surrogate for the proposed field crops (fruiting vegetable group 8
- 10, herb subgroup 19 A, pome fruit group 11
- 10, and timothy forage and hay). Application rate in studies is less than the proposed application rate. 2 . Dermal Dose = [DFR (ug/cm2 ) x TC (cm2/hr) x 0.001 mg/ug x 8 hrs/day x DA ( 100 %)]  body
- weight ( 80 kg). 3 MOE = NOAEL (Short
- and I ntermediate
- term NOAEL 80 mg/kg/day)/Daily Dose (LOC=100)). Inhalation Based on the Agency's current practices, a quantitative occupational post
- application inhalation exposure assessment was not performed for bifenazate at this time primarily because it has a low acute inhalation toxicity

(Toxicity Category IV), has a low vapor pressure (<1 x 10 - 7 torr at 25oC), and is applied at a low use rate (max of 0.75 lb ai/A). However, there are multiple potential sources of post
- application inhalation exposure to individuals performing post
application activities in previously treated areas. These potential sources include v olatilization of pesticides and resuspension of dusts and/or particulates that contain pesticides. The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Sci entific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 (http://www.epa.gov/scipoly /SAP/meetings/2009/120109meeting.html ). The Agency is in the process of evaluating the SAP report as well as available post
- appl ication inhalation exposure data generated b y the Agricultural Reentry Task Force and may , as appropriate, develop policies and procedures, to identify the need for and, subsequently , the way to incorporate occupational post - application inhalation exposure into the Agency's risk assessments. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post - application inhalation exposure assessment for bifenazate. REI Bifenazate is classified in acute Toxicity Category IV for acute dermal, inhalation, and oral toxicity, primary

eye irritation, and primary skin irritation. Bifenazate is a dermal sensitizer by the Magnusson/Kligman method, but not the Buehler method. The 12
- hour REIlisted on the label is adequate to protect agricultural workers from post
- application exposures to bifenazate.Page 22 of 27 **Appendix A**  **. Residential Handler and Post -**  **application Algorithms 1.0**  **Residential Handlers** 1.1 Residential Handler Exposure C alculations 1.1.1 Turf, Gardens and Trees, Indoor Environments Dermal and Inhalation Handler Exposure Algorithm Daily dermal and inhalation exposure (mg/day) for residential pesticide handlers, for a given formulation
- application method combination, is e stimated by multiplying the formulation
application method
- specific unit exposure by an estimate of the amount of active ingredient handled in a day , using the equation below: E = UE * AR * A where: E = exposure (mg/day); UE = unit exposure (mg/lb ai); AR = application rate (e.g., lb ai/ft2 , lb ai/gal); and A = area treated or amount handled (e.g., ft2 /day , gal/day). 1.2 Residential Handler Dose Calculations Dermal and/or inhalation absorbed doses normalized to body weight are calculated as: D = E *AF / BW where: D = dose (mg/kg
- day); E = exposure (mg/day); AF = absorption factor (dermal and/or inhalation); and BW = body weight (kg). **2.0 Residential Post** **- application**  2.1 Gardens and Trees Post
- application Dermal Exposure Algorithm Exposure resulting from contacting previousl y treated gardens and trees while performing phy sical activities is calculated as shown below. Residential post
- application exposure assessment must include calculation of exposure on the day of application. Therefore, though an assessment can present exposures for any day “t ” following the application, it must include “day 0” exposure. E = DFR t * CF1 * TC * ETPage 23 of 27

where : E = exposure (mg/day); DFRt = dislodgeable foliar residue on day "t" (μg/cm 2 ); CF1 = weight unit conversion factor (0.001 mg/μg); TC = transfer coefficient (cm2 /hr); and ET = exposure time (hrs/day). In the absence of chemical
- specific data, DFR t can be calculated as follows: DFR t = AR * F

AR * (1

-F

D ) t * CF2 * CF3 where : DFRt = dislodgeable foliar residu e on day "t" (μg/cm 2 ); AR = application rate (lbs ai/ft2 or lb ai/acre); F AR = fraction of ai as dislodgeable residue following application (unitless); F D = fraction of residue that dissipates daily (unitless); t = post - application day

on which exposure is being assessed; CF2 = weight unit conversion factor (4.54 x 10 8 μg/lb); and CF3 = area unit conversion factor (1.08 x 10 - 3 ft2 /cm 2 or 2.47 x 10 - 8 acre/cm2 ). Absorbed dermal dose, normalized to body weight, is calculated as:
BW AF E D *  where : D = dose (mg/kg
- day); E = exposure (mg/day); AF = absorption factor (dermal and/or inhalation); and BW = body

weight (kg). **Table A -** **X: Gardens, Trees, and “Pick -** **your -**  **own” Farms**

**– Inputs for Residential Post**  **** **application Dermal Exposure Algorithm**  **No tation**  **Exposure Factor (units)**  **Point Estimate(s)**  AR Application rate (mass ai per unit area) **[input]** F AR DFR following application, if chemical
- specific is unavailable (fraction) 0.25 F D Daily

residue dissipation, if chemical
- specific is unavailable

(fraction) 0.10 TC Transfer Coefficient (cm 2 /hr) Gardens a Adults 8400 Children 6 < 11 years old 4600 Trees, Retail Adults 1700Page 24 of 27

**Table A -** **X: Gardens, Trees, and “Pick -** **your -**  **own” Farms**

**– Inputs for Residential Post**  **** **application Dermal Exposure Algorithm**  **No tation**  **Exposure Factor (units)**  **Point Estimate(s)**  Plants (if applicable) a Children 6 < 11 years old 930 Indoor Plants Adults 220

Children 6 < 11 years old 120

ET Exposure

Time (hours per day) Home

activities b Gardens Adults 2.2 Children 6 < 11 ye ars old 1.1 Trees, Retail Plants (if applicable) Adults 1.0

Children 6 < 11 ye ars old 0.50 Indoor Plants Adults 1.0

Children 6 < 11 ye ars old 0.50 “Pick
- yo ur own” Farms (if applicable) Adults 5.0

Children 6 < 11 years old 1.9 BW Body weight

(kg) Adults 80

Children 6 < 11 years old 32 a Transfer coefficient point estimates from a composite distribution assuming equal proportion of time spent conducting various activities. See “Transfer Coefficient” section below. Children 6 < 11 years old TC derived using surface area adjustment (see S ection 2.3 ). b Activity time point estimates from a composite distribution assuming equal proportion of each respective activity . Time for children 6 < 11 years old derived using hrs/day ratio adjustment.Page 25 of 27

**Appendix B**  **. Summary of Occupational and Res idential Non**  **- cancer Algorithms**  Average Dail y Dose Potential daily

exposures for occupational handlers are calculated using the following formulas:

E=UE * AR * A * 0.001 mg/ug where: E = e xposure (mg ai/day), UE = unit e xposure (μg ai/lb ai), AR = m aximum application rate according to proposed label (lb ai A or lb ai/gal), and A = area treated or amount handled (e.g., A/day , gal/day). The daily doses are calculated using the following formula: ADD= E * AF BW where: ADD = average dail y dose absorbed in a given scenario (mg ai/kg/day), E = e xposure (mg ai/day), AF = absorption fa ctor (dermal and/or inhalation), and BW = body

weight (kg). Margin of Exposure Non
- cancer risk estimates for each application handler scenario are calculated using a Margin of Exp osure (MOE), which is a ratio of the toxicological endpoint to the daily dose of concern. The daily dermal and inhalation dose received by occupational handlers are compared to the appropriate POD ( i.e. , NOAEL) to assess the risk to occupational handlers for each exposure route. All MOE values are calculated using the following formula: MOE= POD ADD where: MOE = margin of exposure: value used b y HED to represent risk estimates (unitless), POD = point of d eparture (mg/kg/day), and ADD = average dail y dose absorbed in a given scenario (mg ai/kg/day).Page 26 of 27

**Appendix C**  **. Summaries of Dislodgeable Foliar Residue Studies and Proposed Use in Assessment**  **Proposed Uses for Bifenazate Commodity**  **Foliage Type a**  **Product Name**  **Application**

**Equipment Applicatio** 

**n Rate (lb ai/A)**  **Ma xim**  **um**

**Number Applications**  **Per Season** Herbs subgroup 19 A (except chives, chervil) Unknown Florimite® 50WP Groundboom,

Aerial Airblast 0.5 1 Fruiting vegetable group

8
- 10 smooth Pome fruit group 11
- 10 smooth Timothy forage hay varied Airblast 0.75 1 a. Based on information in the ARTF/ORETF DFR Guidance **DFR Studies Available:** Florimite®

50WP on Spathiphyllum: Dislodgeable Foliar Residue Study (MRID 448597

- 01)
. (HED Review: Memo, L. Venkateshwara,
-Nov
- 2012, D ) This study

was designed to collect data to evaluate dislodgeable foliar residue (DFR) dissipation for the compound bifenazate from Spathiphyllum (Peace Li ly) foliage grown in a greenhouse at one site in Florida. On e field trial was conducted in two greenhouses, one containing treated Spathiphyllum (Peace Lil y) plants and the other containing untreated plants. Primary review of the study was conducted by

Versar Inc., 7 July

2000 (MRID 448597
- 01). The secondary re view was conducted by HED on November __, 2012 (D________). Florimite®

50WP is a wettable powder packaged in water soluble bags which contains 50 % bifenazate as the active ingredient. Floramite ® 50W P was applied with a hand
- held boom sprayer at 0.29 lb ai/A. Three applications were made with a 30 day application interval. DFR samples were collected were up to 28 days after the first two treatments and up to 35 day s after the last treatment. Samples were anal yz ed for combined residues of bifenazate and a breakdown product UCC
- D3598. Study results indicate that the range of DFR values quantified were quite similar after all three applications. The maximum DFR analy zed was 72 μ g/sample (after correction for 68 percent field recovery), found on DAT
- 1 after the first application. DFR values did not decline to <LOQ (i.e. 2 μ g/sample) within the 21
- day sampling period following the first two applications. DFR values did decline to <LOQ b y DAT
- 35 after the third application. Assuming first order kinetics, HED modeled dissipation rates and estimated half lives for bifenazate of 9.9 days in Florida (R2 = 0.8433). **Summary of DFR Values and Regression Analysis Results for Treated S**  **pathiphyllum (Peace Lily) in Greenhouses with**  **Bifenazate (MRID# 448597 -**  **01).**Page 27 of 27 Input/Parameter Site: Florida **Bifenazate** Application Rate (lb ai/A) a Study Target Rate = 0.29 lb ai/A 0.29 lb ai/A Spray Volume (GPA) 5 gallons/1000 ft2 Measured Average Day 0 Residue (μg/cm2 ) 0.151 Predicted Day 0 Residue (μg/cm2 ) b 0.161 Slope
- 0.07 Half
- life (days) 9.9 R2 0.8433 a. The application was conducted using hand
-held boom sprayer . b. Regressions are based on data collected after second application. **Proposed use of DFR data:**

 Use the greenhouse Spathiphyllum (Peace Lily) DFR data to estimate post
- application exposure for h erbs subgroup 19 A (except chives, chervil), fruiting vegetable group 8
- 10, pome fruit group 11
- 10, Timothy forage hay (use predicted values). Crop DFR Data Sites Proposed use of DFR Data Characterization

Herbs subgroup 19 A (except chives, chervil), Fruiting vegetable group 8
- 10, Pome fruit group 11
- 10, Timothy forage hay Spathiphyllum (Peace Lily) (Greenhouse) FL Predicte d DFR values  DFR data collected in greenhouse; is a

conservative estimate.  The formulation in the study is a wettable powder packaged in a water soluble bag whereas in one of the proposed labels (EPA Reg#400
- 514) the formulation is a suspension concentrate (liquid). The second label (EPA Reg#400
- 503) the formulation is a wettable powder in a water soluble bag.  The application rate was lower in the study (0.29 lb ai/A) compared to the proposed label (0.5 lb ai/A and 0.75 lb ai/A).  Application method is not application method for proposed crops.